Manufacturer Guangzhou Wondfo Biotech has urged anyone who has purchased one to check the lot number and expiry date.
Any with a number of DM10220170710E and expiry date of January 2020 should not be used and an alternative kit sought.
The manufacturer estimates more than 58,000 affected tests have been distributed in the UK.
Dr Duncan McPherson, of the Medicines and Healthcare Regulatory Agency, said: “It is important people check the lot number of any Clear & Simple Digital Pregnancy Tests they have purchased to see if they have a product from an affected lot.
“If you have any questions about using digital pregnancy tests, please speak to your healthcare professional.
“Patient safety is our highest priority. We strongly encourage anyone to report any issues with this product, or more generally with any medical device, to our Yellow Card Scheme.”